WO2015188705A1

WO2015188705A1 - Lung volume-reducing elastic implant and instrument

Info

Publication number: WO2015188705A1
Application number: PCT/CN2015/080373
Authority: WO
Inventors: 林伟林; 李思漪; 李安宁
Original assignee: 先健科技(深圳)有限公司
Priority date: 2014-06-11
Filing date: 2015-05-29
Publication date: 2015-12-17
Also published as: CN105455930A; KR101939039B1; JP2017517339A; KR20170016953A; US10342549B2; KR20180125635A; US20180132860A1; JP6732663B2; CN105455930B

Abstract

A lung volume-reducing elastic implant (2) and a lung volume-reducing instrument; the lung volume-reducing elastic implant (2) is tubular and comprises a proximal implant end (201), an elastic deformation part (205) and a distal implant end (202); the elastic deformation part (205) is located between the proximal implant end (201) and the distal implant end (202), and at least the elastic deformation part (205) has shape memory property; the lung volume-reducing elastic implant (2) opens at least at the proximal implant end (201); the elastic deformation part (205) is provided with a plurality of grooves (204) at intervals in the length direction thereof; each groove (204) communicates with the tube cavity of the elastic deformation part (205); the lung volume-reducing instrument comprises the lung volume-reducing elastic implant (2) and a conveying device (1) matching same; the conveying device (1) comprises a guidewire (101) and a hollow push piece (110); the lung volume-reducing elastic implant (2) is detachably connected to the distal end of the hollow push piece (110) via the proximal implant end (201); and the guidewire (101) passes through the tube cavity of the lung volume-reducing elastic implant (2) and the tube cavity of the hollow push piece (110). The lung volume-reducing instrument is more convenient for an operation and takes shorter time, and avoids damage to the inner wall of a bronchia, reducing the occurrence of pneumothorax.

Description

Lung volume reduction elastic implant and instrument

Technical field

The invention belongs to the technical field of interventional treatment, and relates to an implant and an instrument for interventional treatment, in particular to a lung volume reduction elastic implant and a device.

Background technique

In clinical treatment, emphysema is a common lung disease, especially in the elderly. According to statistics, patients with end-stage emphysema are sick 5 The annual survival rate is less than 50% . Traditional emphysema medical treatment includes oxygen inhalation, prevention of pulmonary infection, bronchial spasm, etc., but the curative effect is extremely limited; while the surgical treatment of emphysema is mostly based on lung volume reduction surgery, and there are many limitations. Such as: strict surgical indications, more complications, anesthesia and anesthesia-related complications, preoperative efficacy is difficult to predict, postoperative can not make up for the unsatisfactory results caused by excessive or too little resection, high The cost of surgery and the greater mental and physical pain, and because some patients have poor lung function and often can not tolerate surgery, so the postoperative mortality is higher, which limits the application of surgery.

In order to better treat emphysema, improve the quality of life of patients, and reduce trauma to patients during surgery, international studies have used bronchoscopy to implement one-way flaps, bio-gel, steam thermal ablation, elastic coils and other interventional methods. Treatment of emphysema. The one-way flap has not been effectively and actively discharged due to the residual gas and sputum in the target area, and the clinical indicators are not good. FDA The rejection, in addition to the effectiveness of one-way valve treatment, is also limited by the technical difficulty of collateral ventilation and precise placement into different anatomical locations. The bioglue has completely blocked the emphysema area, and the problem of postoperative inflammation has not been solved well. The thermal ablation of water vapor also destroys the original tissue structure of the emphysema area, leading to postoperative inflammation.

At present, an updated treatment is used for emphysema, that is, the elastic coil is implanted as an implant into the lung lesion site. figure 1 It is a schematic diagram of a lung volume reduction elastic coil of the prior art. The product is made of a nickel-titanium memory alloy wire and can be elastically deformed under external force. Under the constraint of the loading system, the product can be implanted into the lungs through the bronchoscope working channel in a straight strip. When the coil is delivered into the bronchi of the emphysema area, the coil loses the constraint of the loading system and restores the deformation to the figure. 1 The natural shape shown (ie, the shape without external force), while the emphysema area is squeezed by the pulling action of the Nitinol wire, the gas in the bronchi is discharged, and the volume of the lung tissue in the emphysema area is reduced. Thereby, the peripherally relatively healthy lung tissue can better exert physiological functions.

The procedure for using the elastic coil includes three procedures of inserting a bronchoscope, establishing a channel, and implanting a product. The schematic diagram of inserting the bronchoscope is shown in Figure 2. As shown, the bronchoscope 201 is inserted orally or nasally, and the bronchoscope 201 displays an image detected by the bronchoscope distal end 203 on the monitor 204 to guide the bronchoscope 201. Arrived in the bronchial 205 of the human lung.

A schematic diagram of establishing a channel is shown in Fig. 2. The outer diameter of the guide wire 206 is about 5Fr to about 7Fr, and the diameter of the delivery sheath can be about Between 5Fr and 9Fr. The guidewire 206 is advanced through the lumen of the dilator 207, which travels through the lumen of the delivery sheath 208, the guidewire 206, the dilator 207 Once assembled with the delivery sheath 208, it enters the bronchoscope 201 from the working channel 202 of the bronchoscope 201 and enters the bronchus 205 through the distal end 203 of the bronchoscope 201. Inside. The distal end 209 of the guidewire 206 is provided with a length indicia 210 indicating the distance from the distal end 209 along the guidewire 206. The distal end of the delivery sheath 208 211 The logo 210 may be in the form of a plurality of corresponding high contrast metal strips including gold, platinum, rhodium, ruthenium, tungsten, and/or the like. Use with remote imaging capture device 212 A fluoroscopy system, an ultrasound imaging system, an MRI system, a computed tomography (CT) system, or some other remote imaging implant can guide the guidewire 206. Figure 2 The remote imaging capture device 212 can display the detected image on the monitor 213, and the guidewire 206 track or imaging mark 210 is identified by the remote imaging capture device 212. To establish a channel.

After the passage is established, the dilator 207 and the guidewire 206 are withdrawn proximally from the delivery sheath 208 so that the sheath 208 can be delivered. The open cavity is loaded with a lung volume reduction elastic coil 301. A schematic diagram of the implanted coil 301 is shown in Fig. 3, and the loading system 302 carrying the coil 301 is connected through the locking hub 303. Coupled to the proximal end of the delivery sheath 208. The coil 301 is introduced into the delivery sheath, as shown in Figure 4, and the product is pushed out of the delivery sheath 208 by the cable 305 of the actuator 304. The distal end thus enters the bronchi 205, the delivery sheath 208 is withdrawn, and the coil 301 is released by the gripper 306 of the actuator 304. Coil 301 When the initial shape is restored, the bronchi 205 is also pulled into a curl, thereby achieving a therapeutic effect of emphysema volume reduction.

The above implants and their implantation methods have the following drawbacks:

1 The existing elastic coil made of nickel-titanium wire needs to be released through the delivery sheath, and the process of pushing the sheath into the bronchus may cause damage to the inner wall of the bronchus, leading to adverse events such as pneumothorax.

2, due to the large outer diameter of the delivery sheath, about 5Fr to 9Fr Therefore, it is difficult to implant the elastic coil into the lung bypass or the end of some small-diameter trachea through the delivery sheath, and the range of the emphysema area that is squeezed and pulled by the elastic coil is limited, which affects the volume reduction effect.

3 The existing surgical procedure for implanting the elastic coil requires three independent operations of inserting the bronchoscope, establishing the passage, and implanting the product, and the operation time is long, and the operation is performed while the patient is awake, if the operation time Too long, easy to cause patient discomfort and The occurrence of adverse events such as acute exacerbation of COPD.

Summary of the invention

The technical problem to be solved by the present invention is that, in view of the above-mentioned drawbacks in the prior art, an implant that does not employ a delivery sheath and is directly delivered by a guide wire is provided. The use of the implant can prevent the sheath from causing damage to the inner wall of the bronchus and reduce the incidence of pneumothorax.

The technical problem to be further solved by the present invention is to provide an implantation operation process and a surgical operation for implanting an implant into a lung bypass or some small-diameter tracheal end according to actual requirements, combining a channel process and an implant. A lung volume reduction device that is more convenient, reduces the operation time of the operation, and achieves a better therapeutic effect.

One technical solution adopted by the present invention to solve its technical problems is:

A lung volume reduction elastic implant, the implant being tubular and including a proximal end of the implant, an elastic deformation portion and a distal end of the implant, the elastic deformation portion being located at the proximal end of the implant and the implant Between the distal ends and at least the elastic deformation portion The shape has a shape memory property, and the implant body is open at least at the proximal end of the implant body, and the elastic deformation portion is spaced apart along the longitudinal direction thereof with a plurality of slits, and each of the slits communicates with the lumen of the elastic deformation portion.

In an embodiment of the present invention, the lung volume reduction elastic implant has an axially cut plane, and the angle between the slit direction of each slot and the length direction of the elastic deformation portion is 10- 90° And the shape and arrangement of the slots satisfy the elastic deformation portion for multi-directional bending and torsion, and meet the bending stress requirements of the implant.

In an embodiment of the present invention, the implant further includes an elastic film coated on an outer wall of the elastic deformation portion.

In an embodiment of the present technical solution, the elastic film may also cover the entire implant surface and fill into the slit.

In an embodiment of the present technical solution, the outer diameter of the implant is increased from the distal end to the proximal end.

In an embodiment of the present technical solution, the proximal end of the implant is integrally formed with the proximal end of the elastic deformation portion.

In an embodiment of the present technical solution, the distal end of the implant body extends outwardly and is connected with a flexible implant guiding head, and the implant guiding head is coaxial with the distal end of the implant and closes the implant. At the distal end of the body, the implant guide head is provided with a development mark.

In an embodiment of the present invention, in the lung volume reduction elastic implant, the proximal end of the implant is provided with a detachable connecting member.

A technical solution adopted by the present invention further provides a lung volume reduction device, comprising any of the above implants and a conveying device matched with the implant, the conveying device comprising a guide wire and a hollow pushing member, An implant is detachably coupled to a distal end of the pusher by a proximal end of the implant, the guide wire movably threading into a lumen of the implant and a lumen of the pusher .

In an embodiment of the present invention, the distal end of the guide wire is provided with a soft guide wire guiding head coaxial with the guide wire, and the outer diameter of the guide wire guide head is consistent with the outer diameter of the guide wire.

In an embodiment of the present technical solution, the soft guide wire guiding head may be provided with a development mark.

In an embodiment of the present invention, the guide wire guiding head includes a guiding column and a spring fixed to the guiding column, and the guiding column and the guide wire integral structure or the guiding column are fixed to the distal end of the guide wire; With a development mark.

Compared with the prior art, the implant of the invention has a tubular shape and at least the proximal end of the implant is open, and the guide wire can be directly inserted into the lumen of the implant to bind the implant into a straight strip for transport. Therefore, the delivery sheath which is larger than the outer diameter of the implant is no longer needed to restrain the implant, and the damage of the delivery sheath to the trachea during transportation is avoided, and the incidence of pneumothorax is further reduced. Alternatively, the implant can be open at both the proximal end of the implant and the distal end of the implant, or it can be the proximal end of the implant only. When the proximal end of the implant and the distal end of the implant are open, the guide wire can be used to directly guide and establish a passage in the trachea. When the implant is only implanted in the proximal end of the implant, the implant may include a flexible guide head disposed at the distal end of the implant and closing the distal end of the implant, in which case the guide wire may be directly passed The flexible guide head is used to guide and establish a passage in the trachea by inserting into the lumen of the implant and binding the flexible guide. By loading and releasing the guide wire, it can be implanted into the lung bypass or the end of some small-diameter trachea to squeeze the emphysema area to achieve the effect of pulmonary interventional therapy.

The implant of the invention has a hollow lumen structure, which facilitates the passage of the guide wire through the lumen of the implant before the operation, so that the implant is loaded on the guide wire, and the two are pushed together to the lung through the bronchoscope. In the bronchi of the emphysema area, as described above, the guide wire or the implant itself is used to establish a channel, and after the implant is pushed to the appropriate target area, the guide wire is released to release the implant, that is, the established channel of the prior art. The process and the implantation of the implant are completed simultaneously, which can effectively reduce the operation time of the operation and thus avoid Adverse events such as acute exacerbations of COPD.

Furthermore, the implant is covered with an elastic film on the elastic deformation portion or the entire implant, which can avoid direct contact between the metal surface of the implant and the inner wall of the bronchus, and reduce the release of metal elements, thereby effectively reducing pneumonia. Or a small airway infection.

The device of the present invention uses the guide wire to load the implant while guiding the establishing channel and conveying the implant and releasing it; or the soft end of the implant body is provided at the distal end of the implant body, and the implant guiding head can Guide and establish the function of the channel, the implant can be released immediately after the channel is established; using this solution to combine the process of establishing the channel and the implantation process of the implant, the operation is more convenient and the operation time can be reduced.

In the device of the present invention, the delivery device adopts a guide wire to penetrate into the implant having the lumen structure, and is pushed by the push mechanism to complete the delivery of the implant. The guide wire is constrained to make the implant pass the natural state (ie, heat treatment). The predetermined state of the obtained curl is converted into a delivery state (ie, a straight strip shape in accordance with the shape of the guide wire), and after the guide wire is withdrawn from the lumen of the implant, the constraint of the guide wire is released, and the plant can be made The infusion body is transformed from a delivery state to a natural state, thereby achieving the effect of squeezing the target area of emphysema. Compared with the prior art, the delivery device has a smaller diameter, which enables the implant to enter a smaller emphysema target area and achieve a better therapeutic effect. The invention adopts the technical scheme of establishing a channel and releasing the implant, which can shorten the whole operation time and can be more accurately positioned in the target area of the emphysema.

The device of the invention is also coated on the surface of the implant with an elastic membrane, and the elastic membrane is made of a polymer material with better biocompatibility, so that the elastic membrane of the polymer material is in contact with the inner wall of the bronchus, and the prior art The nickel-titanium wire in the direct contact with the inner wall of the bronchus can reduce bronchial inflammation and damage caused by friction between the implant and the inner wall of the bronchus during breathing, thereby reducing the risk of pneumonia and small airway infection. In addition, the metal surface of the implant is coated with an elastic film of a polymer material, which can effectively reduce the release of metal elements.

DRAWINGS

The present invention will be further described below in conjunction with the accompanying drawings and embodiments, in which:

1 is a schematic structural view of a prior art elastic coil;

2 is a schematic view showing the operation of establishing a passage for implanting a bronchoscope and a guide wire in the prior art;

Figure 3 is a schematic view of a prior art conveying elastic coil;

Figure 4 is a schematic view of a prior art release elastic coil;

FIG. 5 is a schematic structural view of an implant according to an embodiment of the present invention; FIG.

Figure 6 is a cross-sectional view of the implant shown in Figure 5;

7 is a schematic view showing a slit of the implant according to an embodiment of the present invention, which is cut along the longitudinal direction thereof and expanded;

FIG. 8 is a schematic view showing a structure of a slit after the elastic deformation portion of the implant is restrained into a straight strip according to another embodiment of the present invention; FIG.

Figure 9 is a partial cross-sectional view of the implant shown in Figure 8;

10 is a development view of an embodiment of a slit of an implant according to still another embodiment of the present invention;

Figure 11 is a partial schematic view showing the elastic deformation portion of the implant shown in Figure 10;

12 is a development view of another embodiment of a slit of an implant according to still another embodiment of the present invention;

Figure 13 is a partial schematic view showing the elastic deformation portion of the implant shown in Figure 12;

14 is a schematic structural view of an implant with a connector and a skeleton guiding head according to an embodiment of the present invention;

15 is a schematic structural view of an implant retaining a partial elastic film according to an embodiment of the present invention;

16 is a schematic view of a lung volume reduction device according to an embodiment of the present invention;

Figure 17 is an enlarged view of I of Figure 16;

18 is a schematic diagram of a working channel for establishing a lung volume reduction device according to an embodiment of the present invention;

Figure 19 is an enlarged view of A of Figure 18;

20 is a schematic view of an implant implanted in an embodiment of the present invention;

Figure 21 is an enlarged view of B of Figure 20.

detailed description

For a better understanding of the technical features, objects and effects of the present invention, the embodiments of the present invention are described in detail with reference to the accompanying drawings.

As shown in FIGS. 5 and 6, a lung volume reduction elastic implant according to an embodiment of the present invention is tubular and includes a proximal end of the implant. 201, an elastic deformation portion 205 and an implant distal end 202, the elastic deformation portion 205 being located between the implant proximal end 201 and the implant distal end 202 and at least the elastic deformation portion 205 Having shape memory characteristics, the implant 2 is at least open at the proximal end 201 of the implant (the proximal end is near the end of the operator), the implant 2 The three components can be a one-piece structure, or the three parts can be realized by a fixed connection.

The elastic deformation portion 205 includes a lumen 207. The elastic deformation portion 205 is provided with a plurality of slots along its axial direction, that is, in the longitudinal direction. 204, the slot 204 is in communication with the lumen 207. The elastic deformation portion 205 is an implant 2 The main structure is a predetermined shape that is curled in a natural state (ie, when it is not subjected to any external force), and can be restrained into a straight strip shape or any other shape under the action of an external force, and is restored to a predetermined state by bending and twisting after the external force is removed. shape. Implant 2 It can be made of a material having a shape memory function which is commonly used in the industry, and the specific material is not limited in the present invention as long as it is suitable for a human body and has a shape memory function. In this embodiment, the implant 2 Made of nickel-titanium alloy, specifically hollow nickel-titanium tube. Specifically, the hollow nickel-titanium tube raw material is laser-engraved to a certain slit 204, and then bent into a predetermined shape, and then heat-treated and shaped to obtain the implant 2 .

Implant 2 The outer and inner diameters are determined by their own characteristics and the outer diameter of the guidewire, ie, as far as possible, to maintain a sufficient elasticity to pull the lung tissue, as far as possible to implant the lung bypass or the end of some small diameter trachea To achieve better therapeutic results. In addition, the implant The inner diameter of 2 needs to be larger than the outer diameter of the guide wire. As an embodiment, the implant 2 has an outer diameter of 0.5 to 2.5 mm and a wall thickness of 0.01 to 0.5 mm.

Implant 2 It is possible to use an equal diameter pipe having the same outer diameter and inner diameter from one end to the other end, and a non-equal diameter pipe having a change in outer diameter and inner diameter. In order to enable the implant 2 to extend into the thinner bronchus, in other embodiments of the invention, The implant 2 is a conical tube whose lumen 207 has a diameter which is gradually thickened from the distal end to the proximal end, that is, the outer diameter of the implant 2 is increased from the distal end toward the proximal end. For example, choose an inner diameter of 0.8-1.0 mm For a conical tube, the wall thickness of the conical tube varies from 0.01 mm at the distal end 202 of the implant to 0.2 mm at the proximal end 201 of the implant.

The presence of the slit 204 enables the elastic deformation portion 205 to perform a curvature with a large curvature, and can also realize the elastic deformation portion 205. Torsing at various angles to form a complex predetermined shape. In the present invention, the arrangement of the slots 204 is not limited, and the slots 204 are generally arranged in parallel, spiral, etc., from the elastic deformation portion. Looking at the 205-week view, the slits 204 may be partially arranged or may be arranged in the circumferential direction of the elastic deformation portion 205. The grooving 204 has a variety of shapes, for example, grooving 204 It is generally a long and narrow structure. On the unfolding plane of the elastic deformation portion 205 which is axially cut, the angle between the slit 204 and the axis of the elastic deformation portion 205 is 10-90°; that is, the slit 204 The angle between the opening direction and the axis of the elastic deformation portion 205 is 10-90°, and the arrangement of the slit 204 is for better bending and torsion, the groove 204 and the elastic deformation portion. The axis of the 205 is not parallel to facilitate the bending of the elastic deformation portion 205, and in the case where the angle α is 90°, the bending of the elastic deformation portion 205 in the same plane is facilitated, and the angle is less than 90°. At the same time, bending and torsion can be achieved so that the elastic deformation portion 205 can be formed in a range of 360°. In other embodiments of the present invention, the angle α between the slot 204 and the axis of the elastic deformation portion 205 is preferably 45-90°. The shape and number of the slits 204, the density of the arrangement, and the position of the slit 204 should satisfy the elastic deformation portion 205 for multi-directional bending and twisting, and the slit 204 The position, number and shape, and the arrangement density are required to meet the bending stress requirements applied to the extruded lung tissue after the implant 2 is implanted into the lung tissue, that is, the implant 2 Do not pierce the bronchi when pulling the tissue in the emphysema area during the process of restoring deformation. The grooving 204 can be specifically set according to actual calculations, so that the implant 2 When implanted into the lungs, it will not cause piercing of the bronchus due to excessive local stress, and also avoid damage to the human body caused by damage and breakage of the implant 2 due to excessive stress.

In this embodiment, as shown in Figs. 7 and 8, a single slit 204 is a dumbbell shape, and the elastic deformation portion 205 shown in Fig. 7 is shown. As can be seen in the planar development view taken along the axial direction, the slit 204 forms an angle α with the axis of the elastic deformation portion 205 of 90°. Multiple slots 204 are equally spaced, all slots 204 Parallel to each other. The dumbbell-shaped slit 204 satisfies the bending and twisting of the elastic deformation portion 205. There is a spacing of 208 between each of the slots 204 of about 0.05-0.5 mm. Elastic deformation The 205 has an outer diameter of 0.5-1.5 mm and a wall thickness of 0.01-0.2 mm.

In still another embodiment of the present invention, as shown in FIGS. 10 and 11, the elastic deformation portion 205 is provided with a plurality of sets of slots 204. . After the elastic deformation portion is axially cut and flattened, each set of slits 204 includes three slits 204a, slits 204b, and slits 204c which are circumferentially arranged along the elastic deformation portion. And both ends of the three slits are aligned with each other in the circumferential direction. The grooving 204a, the grooving 204b, and the grooving 204c have a certain interval 209, and there is a gap between the two adjacent grooving grooves 204. 208. The slits 204 are elongated structures, and the extending directions of the slits 204 form an angle α with the axis of the elastic deformation portion 205. By adjusting the number and spacing of each group of parallel slots 204 209, the angle between the grooving 204 and the axis of the elastic deformation portion 205, and the spacing 208 between the groups of slots 204, the entire elastic deformation portion 205 can be adjusted. The bending stress makes it meet the implant requirements. In other embodiments, the number of slots in each set of slots 204 may be 2-6, and the spacing between adjacent slots 204 may be 0.05-1. Mm, the angle α can be 10-85°, and the interval 208 between each group is 0.1-1.0 mm. The outer diameter of the elastic deformation portion 205 is about 1.0-2.0 mm, and the wall thickness is 0.05-0.3 mm.

In still another embodiment of the present invention, as shown in Figs. 12 and 13, the intermediate portion of the elastic deformation portion 205 is divided into a plurality of sets of oblong sipe. 204, each group of slots 204 is composed of two or more side by side elliptical slots 204. In this embodiment, each group of slots 204 is composed of two parallel slots 204a and slots 204b, and slots are formed. 204a, the slot 204b is iteratively arranged, the slot 204a, the slot 204b has a certain spacing 209, and the angle α between the slot 204 and the axis of the elastic deformation portion 205 is At 90°, the extending direction of the arrangement between the groups forms a certain angle β with the axis of the elastic deformation portion 205. The angle β can be 60-90°, and there is about 0.3-5 between each group of slots 204. The pitch of mm is 208, and the groovings 204 of each group are arranged in a stepwise periodic manner. For example, 5-20 sets of grooving 204 may be a cycle, and the stepped periodic grooving 204 is beneficial to the elastic deformation part. The elastic deformation portion 205 of 205 is bent into a specific shape. The proximal end of the elastic deformation portion 205 has a proximal end 201 of about 1.5-10 mm length and a distal end 202 of the implant, proximal end of the implant 201 has a length of about 0.5-5 mm cut into a threaded groove as the connecting member 210. Then use the mold to bend the cut implant 2 into a figure 14 The shape shown is heat treated and shaped into the implant 2 described. In the present embodiment, the implant 2 has an outer diameter of 1.2-2.5 mm and a wall thickness of 0.1-0.4 mm.

As shown in Figures 5 and 14, the two ends of the elastic deformation portion 205 are the proximal end 201 of the implant and the distal end of the implant 202, respectively. The implant proximal end 201 is used to set the connector 210 and the distal end 202 of the implant is used to advance into the trachea. Implant proximal 201 A connecting member 210 for detachably connecting with a pushing mechanism (such as a hollow push cable) is connected. The detachable connecting method in the present invention means that the connecting member 210 before pushing and during pushing. Fixed with the push mechanism, the connector 210 is disengaged from the push mechanism when pushed into position. The connector 210 has a variety of structures and connections for detachable connections, such as shown in Figure 5, with a threaded connection to the proximal end of the implant. 201 Welded with a female threaded connection 210. When assembled, it can be screwed with the external thread provided by the pushing mechanism; after the push reaches the corresponding position, the connecting member 210 is passed through the torsion pushing mechanism. Can be separated from the push mechanism. Obviously, based on the prior art, the connector 210 can also be other components that can be detached from the fixed connection, such as magnetic connecting devices, elastic snaps, lassos, etc., respectively disposed at the proximal end of the implant of the implant 2. On the 201 and push mechanism, the detachable fixed connection is achieved. Or directly driving the internal thread directly at the proximal end 201 of the implant (i.e., the proximal end 201 of the implant is part of the elastic deformation portion 205), as shown in the figure 14, the connecting member 210 disposed at the proximal end 201 of the implant is a spiral connecting hook, and the same pushing mechanism is also provided with a spiral connecting hook, and the two are rotated and hooked together to insert the implant 2 It can be detachably fixedly attached to the distal end of the push mechanism.

As shown in Fig. 14, in order to allow the implant 2 to smoothly enter the trachea, the implant distal end 202 is not open when the distal end of the implant 2 is not open. Extendingly coupled to a flexible implant guide head 211, the implant guide head 211 is coaxial with the implant distal end 202 and encloses the implant distal end 202, the implant guide head 211 A development mark is provided. The implant guide head 211 has a function of guiding and establishing a passage, and may be integrally formed with the distal end 202 of the implant, or may be additionally fixed to the distal end 202 of the implant. Implant head The 211 has relative flexibility to avoid scratching the tracheal wall after entering the trachea. The purpose of the development mark setting is to facilitate monitoring during the push process. The development mark can pass the fluoroscopy system, the ultrasound imaging system, and the MRI. The identification of the implant by the system, computed tomography (CT) system or other remote imaging, the specific structure is not limited. The implant 2 is displayed and guided by these systems, in this embodiment A wire with a diameter of 0.1-0.5 mm and a relatively strong X-ray developable tungsten, tantalum or the like is wound with a length of about 1-10 mm as a developing mark. This embodiment will develop the identification mark and the implant guide head 211 merge into one part to achieve two functions. In addition to this, a development mark such as a developing ring may be additionally provided on the implant guiding head 211, and the developing ring is sleeved on the implant guiding head 211. On.

As shown in FIGS. 6 and 9, in the above various embodiments, the elastic deformation portion 205 may be covered with an elastic film 206. . As an embodiment, the elastic membrane 206 completely covers the elastic deformation portion 205, the proximal end 201 of the implant, and the distal end 202 of the implant, facilitating the overall implant 2 The trachea is not damaged during implantation. The elastic film 206 can also be filled into the slit 204 to ensure that the surface of the implant 2 is smooth as a whole, and the elastic film 206 is filled in the slit 204 to also make the elastic film 206 can be more firmly coated on the surface of the implant 2. At the same time, in order to ensure the smoothness in the lumen 207 of the elastic deformation portion 205, the inner wall and the elastic deformation portion formed by the elastic film 206 in the slit 204 are formed. 205 The inner wall of the lumen 207 is flush. The elastic film 206 may have a thickness of 0.01 to 0.3 mm. The elastic film 206 It can be made of polymer materials with excellent chemical stability, water resistance, weathering resistance, good low compressibility, good biocompatibility, high mechanical strength, non-toxicity and odorless properties. For example, these polymer materials may be silicone rubber or polyurethane materials. With implant guide head At 211, the elastic film 206 simultaneously wraps the elastic deformation portion 205 and its implant guiding head 211 to form an elastic film 206 of a unitary structure.

Figure 15 is a cross-sectional view of an implant 2 with a retained partial elastic membrane 206, an elastic deformation portion 205, in accordance with an embodiment of the present invention. The deformation portion includes a plurality of sets of slots 204. The elastic deformation portion 205, the proximal end 201 of the implant, the distal end 202 of the implant, and the surface of the implant guiding head 211 are covered with an elastic membrane 206. .

It is worth mentioning that the lung volume reduction elastic body 2 of one embodiment of the present invention is open at both ends, that is, the proximal end of the implant 201 and the distal end of the implant 202. The ends are open and may not include the implant guide head 211.

An embodiment of the present invention further provides a lung volume reduction device, as shown in FIG. 1-21, comprising an implant 2 and a delivery device 1 , the implant 2 The tubular structure having shape memory characteristics has a main body which is an elastic deformation portion 205, and the elastic deformation portion 205 has a lumen 207; the two ends of the implant 2 are the proximal end of the implant 201 And the distal end 202 of the implant, the wall of the elastic deformation portion 205 is provided with a plurality of slits 204, and the slit 204 penetrates into the lumen 207 of the elastic deformation portion 205; 1 includes a guide wire 101 and a push mechanism 110 (the push mechanism 110 generally includes a hollow pusher member, i.e., a hollow steel cable 103 and a steering handle connected to the push cable 103) The implant 2 is detachably coupled to the distal end of the push mechanism 110 by a connector 210, and the implant 2 and the push cable 103 are respectively fitted to the guide wire 101. Further, the guide wire 101 is loaded in the implant 2 and the push cable 103, and the implant 2 is movable along the guide wire 101.

In the delivery device 1, the guide wire 101 is used to carry the implant 2, guide and establish a channel, and the implant 2 is integrally placed on the guide wire 101. Further, the implant 2 is constrained by the guide wire 101 into a straight strip shape, that is, the implant 2 is stretched by the guide wire 101 into a straight conveying state in conformity with the guide wire 101 to facilitate entry into the trachea.

Referring to Fig. 16, a guide wire 101 can be inserted from the proximal end 201 of the implant 2, and the guide wire 101 can be used with a diameter of Made of 0.1-1.1 mm wire. The purpose of the guide wire 101 is to establish a channel and implant the implant 2 The delivery to the lesion site eliminates the need to transport the sheath to bind the implant, thereby avoiding damage to the trachea during delivery, further reducing the incidence of pneumothorax. The wire has a certain rigidity and toughness, can be properly bent, conforms to the shape of the trachea, and can be gradually advanced along the trachea. Compared to the prior art, the implant is no longer needed, and the implant is no longer needed. 2 Implantable lung bypass or the end of some small diameter trachea for better therapeutic results.

In order to be safe and convenient to operate, it is necessary to provide a flexible guide wire guide head coaxial with the guide wire 101 and having a development mark at the distal end of the guide wire 101. 102. The outer diameter of the guide wire guiding head 102 is the same as the outer diameter of the guide wire 101. As shown in Fig. 17, the guide wire guiding head 102 includes a guide post 102a and a guide post 102a. The outer sleeve fixed spring 102b, the guide post 102a and the guide wire 101 are integrally formed or the guide post 102a is fixed to the distal end of the guide wire 101; the spring 102b With a development logo.

The guide wire guiding head 102 is the distal end of the guide wire 101 The soft treatment can effectively avoid damage to the tracheal wall when the trachea is implanted. The flexible guidewire guide 102 can be realized by a spring having a soft feature, i.e., integral with the guidewire 101 or attached to the guidewire 101. The distal guide post 102a is fitted with a spring 102b. The specific manufacturing may be: the tip end of the guide wire 101 is refined to form a guide post 102a, and the length of the guide post 102a is fixed to a length of 5-150 mm spring 102b. Spring 102b and guide wire 101 The fixing method may be a polymer heat shrinkable tube or a film coating, a glue bonding, a laser welding, a soldering or the like. Guidewire 101 is guided from the proximal end of implant 2 of implant 2 under the guidance of a flexible guidewire guide 102 It can smoothly enter the lumen of the elastic deformation portion 205, and the implant 2 can be restrained from the shape shown in Figs. 5 and 6 into a straight conveying state, as shown in Fig. 16. Obviously, based on the prior art, the implant is loaded The guide wire 101 of 2 also has the function of guiding and establishing a passage in the bronchus. Since the operating condition of the guide wire 101 into the lungs needs to be guided and monitored, it is set on the guide wire guide 102. Development mark. The development mark can pass the fluoroscopy system, ultrasound imaging system, MRI system, computed tomography (CT) The identification of the display by the system or other remote imaging, the specific structure is not limited. The guide wire 101 is displayed and guided by these systems, and in this embodiment, a wire diameter of 0.01-0.3 mm is used. A spring wound with a wire such as tungsten or tantalum with strong X-ray developability is used as a development mark. This embodiment will develop the identification mark and the guide wire guiding head 102. Merge into one component to achieve two functions. In addition to this, it is also possible to guide the head 102. A development mark is additionally set on the upper side. Of course, when the surface of the implant of the present invention is not coated with an elastic film and is made of a material that can be developed by itself, such as a nickel titanium alloy, the development mark may not be included.

In order to facilitate the delivery of the guide wire 101, a guide wire handle 105 is provided at the proximal end of the guide wire 101 for conveying the guide wire 101. , or after the implant 2 is delivered into place, the guide wire 101 is withdrawn.

Specifically, the push mechanism 110 includes a hollow push cable 103, and a steering handle 106 coupled to the push cable 103. The push cable 103 and the implant 2 are both set on the guide wire 101, and the distal end of the push cable 103 is connected to the proximal end of the implant 2 210 Connected. The connection is detachably connected by a coupling fitting 109 provided at the distal end of the connector 210 of the implant 2 and the push cable 103, respectively. Connector 210 and connection fitting 109 There are a variety of configurations and connections, such as a threaded connection, a connector 210 with internal threads welded to the proximal end 201 of the implant 2, or directly at the proximal end of the implant 201 Directly drive the internal thread as a connector 210. An externally threaded connecting fitting 109 is provided at the distal end of the push cable 103, and the internal thread of the connecting member 210 and the pushing mechanism 110 can be assembled during assembly. With the externally threaded connection, the implant 2 is securely attached to the distal end of the push cable 103; after the implant 2 is pushed to the corresponding position, the steering handle of the cable 103 is pushed by twisting 106 Then, the connecting member 210 of the implant 2 and the connecting fitting 109 of the push cable 103 are spun out. Connector 210 and connection fitting 109 Other detachable fixed connecting members, such as magnetic connecting devices, elastic snaps, lassos, etc., are respectively disposed on the implant proximal end 201 of the implant 2 and the push cable 103 for detachable connection. . As shown 16, the connecting member 210 disposed at the proximal end 201 of the implant is a spiral connecting hook, and the distal end of the push cable 103 is also provided with a spiral connecting hook, and the two are rotated and hooked together to be implanted. Body 2 The detachable fixed connection is at the distal end of the pushing mechanism 110, and after the implant 2 is pushed into position, the steering handle 106 of the push-pull cable 103 is reversely rotated, and the two helical connecting hooks are separated from each other.

The assembly of the implant 2 with the guide wire 101 can be accomplished by means of a loader during production assembly. First, the implant 2 By inserting into the loader, the implant body 2 which is curled in a natural state can be restrained into a tube in a straight strip conveying state by the limitation of the loader space, and the guide wire 101 assembled with the pushing mechanism 110 can be implanted. Body 2 The implant proximal end 201 is inserted and passed through the implant distal end 202 of the implant 2 until the guidewire guide 102 of the guidewire 101 is threaded out of the distal end of the implant 2 of the implant 2 Stopping, or with the implant distal end 202 closed by the implant guide head 211, the guidewire 101 is inserted through the implant proximal end 201 of the implant 2 and inserted into the implant 2 implant distally end 202 stops, at which point the loader can be unloaded, the implant 2 has been loaded into a straight delivery state under the constraint of the guide wire 101, and the connection fitting of the distal end of the push cable 103 in the push mechanism 110 will be 109 is connected to the connector 210 of the implant 2.

Referring to Figures 18-21, the guide wire 101 of the implant 2 is sheathed through the working channel 902 of the bronchoscope 901. Into the bronchus 904 of the lung 903, with the aid of X-rays, after the passage of the guide wire 101, the implant 2 is used along the guide wire 101 by the push cable 103. Pushing to the guide wire guiding head 102, the guide wire 101 is withdrawn, and the guide wire 101 is withdrawn, and the implant 2 is guided by the guide wire 101 as shown in Figs. The straight-line conveying state that is restrained automatically returns to the natural shape shown in Figs. 20 and 21, and the recovery process can squeeze and pull the emphysema area. The peripherally relatively healthy lung tissue can better exert its respiratory physiological function, thereby achieving the effect of lung volume reduction. The push cable can then be released by rotating the steering handle 106 of the cable 103. The distal connecting fitting is threadedly coupled to the connector 210 of the implant 2 to release the implant 2.

Claims

A lung volume reduction elastic implant characterized in that the implant is tubular and includes a proximal end of the implant, an elastic deformation portion and a distal end of the implant, and the elastic deformation portion is located at the proximal end of the implant And at least the elastic deformation portion between the distal end of the implant The shape has a shape memory property, and the implant body is open at least at the proximal end of the implant body, and the elastic deformation portion is spaced apart along the longitudinal direction thereof with a plurality of slits, and each of the slits communicates with the lumen of the elastic deformation portion.
According to claim 1 The lung volume reduction elastic implant is characterized in that, in an unfolding plane in which the implant body is axially cut, an angle α between the slit direction of each slit and the longitudinal direction of the elastic deformation portion is 10- 90° And the shape and arrangement of the slots satisfy the elastic deformation portion for multi-directional bending and torsion, and meet the bending stress requirements of the implant.
According to claim 2 The lung volume reduction elastic implant is characterized in that the implant further comprises an elastic membrane covering at least an outer wall of the elastic deformation portion.
The lung volume-reducing elastic implant according to claim 3, wherein the elastic film further fills the slit.
The lung volume-reducing elastic implant of claim 1 wherein said outer diameter of said implant increases from a distal end to a proximal end.
According to claim 1 The lung volume reduction elastic implant is characterized in that a distal end of the implant body extends outwardly and is connected with a flexible implant guiding head, and the implant guiding head is coaxial with the distal end of the implant body. And closing the distal end of the implant, the implant guiding head is provided with a development mark.
The lung volume-reducing elastic implant of claim 1 wherein the proximal end of the implant is provided with a detachable connector.
A lung volume reduction device characterized by comprising the claims 1-7 The implant and the delivery device associated with the implant, the delivery device comprising a guide wire and a hollow pusher, the implant being detachably coupled to the proximal end of the implant At the distal end of the pusher, the guidewire is movably threaded into the lumen of the implant and into the lumen of the pusher.
According to claim 8 The lung volume reduction device is characterized in that the distal end of the guide wire is provided with a soft guide wire guiding head coaxial with the guide wire, and the outer diameter of the guide wire guide head is consistent with the outer diameter of the guide wire.
According to claim 9 The lung volume reduction device is characterized in that the guide wire guide head comprises a guide post and a spring fixed to the guide post, and the guide post and the guide wire integral structure or the guide post are fixed at the distal end of the guide wire; The spring has a development mark.